Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
Public ClinicalTrials.gov record NCT01623323. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 3-Month Open-Label Multicenter Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 3-month open-label treatment phase. The duration of each subject's participation is approximately 13 weeks.
Study identification
- NCT ID
- NCT01623323
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 705 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2013 (Type not available)
- Primary completion
- Mar 2015 (Actual)
- Completion
- Mar 2015 (Actual)
- Last update posted
- Aug 29, 2016
2013 – 2015
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Precision Trials | Phoenix | Arizona | 85032 | — |
| Colorado ENT and Allergy | Colorado Springs | Colorado | 80909 | — |
| Sher Allergy | Largo | Florida | 33778 | — |
| ENT of Georgia | Decatur | Georgia | 30030 | — |
| Best Clinical Trials | New Orleans | Louisiana | 70115 | — |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | — |
| Clinical Research Group of Montana | Bozeman | Montana | 59718 | — |
| ENT and Allergy Associates | New Windsor | New York | 12553 | — |
| ENT and Allergy Associates | West Nyack | New York | 10994 | — |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | — |
| Allergy Associates Research Center | Portland | Oregon | 97202 | — |
| Live Oak Allergy and Asthma Clinic | Live Oak | Texas | 78233 | — |
| Texas Quest Medical Research | San Antonio | Texas | 78256 | — |
| Focus Clinical Research | Draper | Utah | 84020 | — |
| InterMountain Ear Nose and Throat | Salt Lake City | Utah | 84102 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
| Premier Clinical Research | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01623323, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 29, 2016 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01623323 live on ClinicalTrials.gov.